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Long-Term Follow Up of CLN6 Batten Disease Subjects Following Gene Transfer

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Lead sponsor: Amicus Therapeutics to Emily de los Reyes
    • Primary completion date: Oct 2024 to Dec 2026
    • Study completion date: Oct 2024 to Dec 2027
    v6
  2. Primary and study completion dates: Jan 2035 to Oct 2024
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 18 words
    v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 13 to confirmed 10
    • Site details revised
    v4
  4. Study description shortened, about 3 wordsv3
  5. Site contact updatedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a long-term safety and efficacy study in subjects with CLN6 Batten disease who previously received a single intrathecal administration of AT-GTX-501.
Trial Details
NCT Number NCT04273243
Lead Sponsor Emily de los Reyes
Conditions
(from sponsor)		 CLN6, Batten Disease
Related terms Neuronal Ceroid-Lipofuscinoses
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov